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Companion Diagnostics in the COVID-19 Era: Market Analysis and Opportunities

  • ID: 5178313
  • Report
  • June 2020
  • Region: Global
  • 180 Pages
  • Kalorama Information
1 of 3

FEATURED COMPANIES

  • Abbott Diagnostics
  • Biocartis
  • Foundation Medicine, Inc.
  • Guardant Health, Inc.
  • Illumina, Inc.
  • Myriad Genetics, Inc.
  • MORE

This report provides a comprehensive market analysis and business planning tool for the market for tests that are aligned with pharmaceutical treatment.  Especially in oncology, companion diagnostics are rising to the forefront of pharmaceutical development and treatment. Companion diagnostics increase the probability of clinical success by identifying patients with the presence of biomarkers or disease-specific therapeutic targets that can dramatically improve outcomes.   Companion diagnostics can also decrease costs by identifying the patient population that will most likely benefit from the therapy and ruling out therapies that are not likely to be effective.   But what is the market for these therapy/test combinations?  And who is winning in the quest to develop them?  How much will the market be in the future?  What specific drugs are seeing test product approvals, and sales of those products?  How has COVID-19 impacted the sector?  This resource provides answers to these questions and more.

As part of its coverage, this report provides:

Sense of the Market

  • COVID-19 impacts on Companion Diagnostics- Where are We Now?
  • Top Performing Targeted Therapies in Oncology with CDx Component, based on 2019 Sales
  • FDA Cleared/Approved Companion Diagnostic Tests, 2010-2020
  • Global In Vitro Companion Diagnostic (CDx) Market, 2019-2024 ($ millions)
  • Global In Vitro Companion Diagnostic (CDx) Market by Region

Regulatory Picture

  • FDA changes in CDx regulation: Shifting to Drug Classification CDx Labeling
  • FDA Approved Companion Diagnostics Labeled for Identifying Patients with NSCLC whose Tumors have EGFR Exon 19 Deletions or Exon 21 (L858R) Substitution – Mutations and the Associated Therapeutic Products Listed on the Companion Diagnostic Labels
  • EU Companion Diagnostic Regulation Guidance

Competitive Analysis

  • Selected Companies offering Companion and Complementary Diagnostics for Autoimmune Disorder Therapies
  • Selected Companies offering Companion and Complementary Diagnostics for Cardiology and Hematology Therapies
  • Selected Companies offering Companion and Complementary Diagnostics for Infectious Disease Therapies Human Leukocyte Antigen (HLA) and COVID-19
  • Selected Companies offering Companion and Complementary Diagnostics for Neurology Therapies, including Psychiatry

Deep Dives into the CDx Market

  • Estimated Value of Other (non-oncology) Companion Diagnostics by Cancer Type, Distribution 2019 (%)
  • Distribution of Commercialized Targeted Therapies Revenues, using CDx by, Drug Class (Kinase Inhibitor, Monoclonal Antibody, Poly ADP Ribose Polymerase Inhibitor, Apoptosis Inducer, PI3K Inhibitor, Other)
  • Market Value of Commercialized Targeted Therapies compared to Companion Diagnostic Market Value, 2015-2019 Dx Approvals (PMAs) by Technique, 2010-2020
  • FDA Approved Companion Dx by Technique (IHC, PCR, FISH, NGS) and Year
  • Global CDx Market by Region (US, EU, Asia, ROW), 2019-2024  

The emergence of new technology has opened doors for companion diagnostic research, discovery, development and commercialization. This has resulted in a huge increase in exploratory studies, diagnostic developments, and clinical usefulness in the pursuit of personalized medicine. Companion diagnostics and biomarkers provide insight into understanding disease processes and ways that medicines can work to counteract the disease. Novel biomarkers and subsequent companion diagnostics have the potential to transform the current healthcare model from a one-size-fits-all approach to a personalized approach

Companies Covered:

  • Abbott Diagnostics
  • Agilent Technologies Inc./Dako
  • Biocartis
  • Foundation Medicine, Inc.
  • Guardant Health, Inc.
  • Illumina, Inc.
  • Myriad Genetics, Inc.
  • Neogenomics
  • Qiagen N.V.
  • Roche Diagnostics
  • Thermo Fisher Scientific Inc.

The entire medical industry is in transition. The number of elderly individuals is increasing, leading to a higher demand for new and better medical technology products. However, governments are trying to limit and lower public health care costs by instituting restrictions and in a more recent example, a planned health system reform in the United States. The main goals of this reform are cost savings and increased efficiency. This is where companion diagnostics can be important to the delivery of care.

This report provides a tool for understanding that market and is one of the analyst's most popular report topics.

Note: Product cover images may vary from those shown
2 of 3

FEATURED COMPANIES

  • Abbott Diagnostics
  • Biocartis
  • Foundation Medicine, Inc.
  • Guardant Health, Inc.
  • Illumina, Inc.
  • Myriad Genetics, Inc.
  • MORE

Chapter 1: Executive Summary and COVID-19 Developments

  • Overview
  • Definitions of Companion Diagnostics and Personalized Medicine Used in This Report
  • Terms Used in Companion Diagnostics and Personalized Medicine
  • COVID-19 CDx Test Volume Impact: Minimal Ongoing Significant Disruptions
  • Biomarker Development: COVID-19 Focus
  • Addressing COVID-19 with a Personalized Medicine Approach
  • Scope and Methodology
  • Market Summary

Chapter 2: Introduction to Personalized Healthcare and Companion Diagnostics

  • Overview
  • Regulatory Changes
  • FDA changes in CDx regulation: Shifting to Drug Classification CDx Labeling
  • EU Companion Diagnostic Regulation Guidance
  • The FDA and Identifying Pharmacogenetic Associations
  • Reimbursement Breakthroughs and Challenges
  • Next Generation Sequencing Coverage
  • CDx Approvals: United States FDA
  • The Market for Targeted Therapies: Oncology
  • Targeted Therapies in Development
  • Development in NGS for CDx
  • Next Generation Sequencing or Massively Parallel Sequencing in Cancer Diagnostics
  • The Evolving Opportunity in Japan
  • Disease Profiles in CDx Markets
  • Cancer
  • Cardiovascular Disease
  • Selected Blood Disorders
  • Autoimmune and Immunological Diseases
  • Infectious Diseases

Chapter 3: Companion Dx Market Analysis

  • Market Overview
  • Biomarkers in Therapeutic Labeling
  • Companion Diagnostics in Oncology
  • Market Review and Outlook
  • Companion Diagnostics in Other Diseases
  • Overview
  • Autoimmune Disorders
  • Cardiology and Hematology
  • Infectious Disease
  • Human Leukocyte Antigen (HLA) and COVID-19
  • Neurology
  • Market Review and Outlook
  • Diagnostic Techniques
  • Market Overview
  • Immunohistochemistry (IHC)
  • In Situ Hybridization
  • Nucleic Acid Amplification Technologies
  • Sequencing Technologies
  • Flow Cytometry
  • Microarrays
  • Mass Spectrometry
  • Liquid Biopsies – Circulating Tumor Cells and Circulating Tumor DNA (Cell Free DNA)
  • Analysis of Gene Expression Patterns (Gene Signatures)
  • Information Technology
  • Regional Market Review
  • U.S. Market
  • European Market
  • Reimbursement in European Markets
  • Japanese Market
  • Chinese Market
  • Rest of World Market

Chapter 4: Competitive Analysis

  • Competitive Landscape
  • Alliances, Acquisitions and Collaborations
  • Competitor Analysis
  • CDx Product Mix: Leading IVD Companies

Chapter 5: Market Participant Profiles

  • Profile Scope
  • Abbott Diagnostics
  • Company Overview
  • Financial Review
  • Product Overview: Companion Dx
  • Agilent Technologies Inc./Dako
  • Company Overview
  • Financial Review
  • Product Overview: Companion Dx
  • Biocartis
  • Company Overview
  • Financial Review
  • Product Overview: Companion Dx
  • Foundation Medicine, Inc.
  • Company Overview
  • Financial Review
  • Product Overview: Companion Dx
  • Guardant Health, Inc.
  • Company Overview
  • Financial Review
  • Product Overview: Companion Dx
  • Illumina, Inc.
  • Company Overview
  • Financial Review
  • Product Overview: Companion Dx
  • Myriad Genetics, Inc.
  • Company Overview
  • Financial Review
  • Product Overview: Companion Dx
  • NeoGenomics
  • Company Overview
  • Financial Review
  • Product Overview: Companion Dx
  • QIAGEN N.V.
  • Company Overview
  • Financial Review
  • Product Overview: Companion Dx
  • Roche Diagnostics
  • Company Overview
  • Financial Review
  • Company Overview: Companion Dx
  • Thermo Fisher Scientific Inc.
  • Company Overview
  • Financial Review
  • Product Overview: Companion Dx
Note: Product cover images may vary from those shown
3 of 3
  • Abbott Diagnostics
  • Agilent Technologies Inc./Dako
  • Biocartis
  • Foundation Medicine, Inc.
  • Guardant Health, Inc.
  • Illumina, Inc.
  • Myriad Genetics, Inc.
  • Neogenomics
  • Qiagen N.V.
  • Roche Diagnostics
  • Thermo Fisher Scientific Inc.
Note: Product cover images may vary from those shown
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